Outsourcing in Clinical Trials USA - Virtual Conference

Biography: Lesley Schofield has been in the pharmaceutical industry for over 25 years, starting with preclinical drug development and then moving on to clinical trial management in late phase clinical research. As a director of US Medical Affairs Clinical Trial Operations, she has the responsibility to lead a team in driving the design and implementation of innovative clinical trials across therapeutic areas. Lesley’s experience and skills include clinical trial design experience (with an emphasis on late phase, neuroscience and cardiovascular clinical research); clinical trial management with a focus on innovating the clinical operations process, protocol development, CRO/vendor selection and management, forming and maintaining strategic collaborations; identifying programmatic challenges and opportunities and developing result-driven operational strategies.

Session Details: Keynote Address – Pandemic Preparedness for clinical trials – what have we learned? 30-09-2020, 9:00 am View In Agenda

Biography: With over 15 years healthcare industry sales experience, I am strongly passionate about biotechnology, and clinical trials. I currently work for Novotech, the Asia Pacific CRO. Contact me to learn more about my experiences serving clients, and conducting clinical trials in the Asia Pacific region.

Session Details: Accelerating Clinical Trials in Asia-Pacific 30-09-2020, 9:30 am View In Agenda

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Session Details: Shaping the Future of Clinical Trial: What’s Coming Up Next in Digital Medicine and Innovative Technology 30-09-2020, 10:00 am PANEL DISCUSSION: Novel Digital Endpoints in Clinical Research: Technology, Infrastructure, Relationship with Technology Providers 30-09-2020, 3:40 pm View In Agenda

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Session Details: Achieving the Holistic Patient View: Marrying Traditional and Novel Data Sources to Enhance Insights 30-09-2020, 10:30 am View In Agenda

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Session Details: Achieving the Holistic Patient View: Marrying Traditional and Novel Data Sources to Enhance Insights 30-09-2020, 10:30 am View In Agenda

Biography: Kristi Koontz is currently the Head of US Clinical Operations for GSK.   Prior to this, she has held a variety of roles across clinical development and global medical affairs.  Kristi has established numerous oncology corporate and academic and alliance partnerships, life cycle strategies, external engagement initiatives, and advocacy partnerships. She holds a BS in Biology from The Pennsylvania State University, an MBA from LaSalle University, and is finishing her PhD in Business Psychology from The Chicago School.

Session Details: Exploring How Best to Manage a Shifting Portfolio 30-09-2020, 11:00 am View In Agenda

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Session Details: PANEL DISCUSSION: Novel Digital Endpoints in Clinical Research: Technology, Infrastructure, Relationship with Technology Providers 30-09-2020, 3:40 pm View In Agenda

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Session Details: How Many Internal ClinOps resources should you have for study startup? 30-09-2020, 11:20 am View In Agenda

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Biography: Stacy Weil is the Senior Vice President, Clinical Data Operations, Strategic Business Optimization at Premier Research. Stacy’s focus is on translating the organization strategy into actionable data initiatives that ultimately enable internal and external customers to achieve the highest level of performance and success. Prior to her role at Premier Research, Stacy worked in the role of Vice President of Clinical Data Operations at PatientiP and held prior roles in leadership in the Process Improvement, Data Analytics, Learning Services and Project Management groups at PPD. Stacy’s operations experience includes project management and therapeutic leadership in the areas of Endocrine/Metabolic, Immunology, Urology, Women’s Health, Neuroscience, and Respiratory. Stacy’s trial oversight includes both global and domestic trials with teams in the US, Canada, Latin America, Asia Pacific and European Union.

Session Details: Real-World Data and the FDA: How to Make Sure Your Data Counts 30-09-2020, 11:40 am View In Agenda

Biography: Kristi Miller leads the team of regulatory professionals in providing strategic and tactical guidance across therapeutic areas and disciplines (CMC, Nonclinical, Clinical, Device and Regulatory Writing). She has over 15 years of experience in the pharmaceutical industry in delivering both regional and international regulatory strategy for pharmaceutical and biotech drug development teams.  Her experience encompasses providing regulatory leadership and execution of strategy for products across development (pre-IND through post marketing) in multiple therapeutic areas of immunology/inflammation, ophthalmology, oncology and other rare diseases.  Her accomplishments include leading teams to successful global health authority interactions, INDs, orphan drug applications, fast track applications, pediatric strategies, and marketing applications. Kristi received her PhD in tumor cell biology and her previous roles have included positions at Pharmacyclics, and Genentech.

Session Details: Real-World Data and the FDA: How to Make Sure Your Data Counts 30-09-2020, 11:40 am View In Agenda

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Session Details: Resource options for the evolving needs of emerging biotechs 30-09-2020, 11:50 am View In Agenda

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Session Details: Resource options for the evolving needs of emerging biotechs 30-09-2020, 11:50 am View In Agenda

Biography: Aditi Khurana, is an Associate Director of Project Management with Jazz Pharmaceuticals, Palo Alto, CA. She is a Project Management Professional (PMP) and is certified in Global Regulatory affairs (RAC). She holds a Bachelors in Neuroscience from University of California Los Angeles, and a Master of Business Administration from University of Illinois Urbana-Champaign. She has 11 years of combined experience working initially in the biomarker identification, companion diagnostics & assay development space as an ASCP licensed Clinical Cytogenetics and Molecular Biologist, and later in project management roles leading planning for clinical development and regulatory submissions deliverables. Key areas of focus include study concept development, IND and BLA submission planning, decision frameworks and developing strategic roadmaps for global product success.

Session Details: Navigating Oncology Landscape- A Regulatory Perspective 30-09-2020, 12:10 pm View In Agenda

Biography: Gowri Sukumar is the Director, CMC and Regulatory Affairs for Iterion Therapeutics, Houston, TX. Unique to her experience is leading all the technical disciplines of CMC development as well as regulatory Affairs. She has broad responsibilities that include process development, Drug Substance and Drug Product manufacturing from the CMC side. From the Regulatory affairs perspective, she provides regulatory leadership and expertise for regulatory strategy, liaises with the regulatory agencies including FDA, Health Canada and other Health authorities. For her leadership approach, she brings a strong focus beyond the necessary technical disciplines and regulations, looking at the interplay of culture and teamwork for successfully advancing programs in an effective and efficient manner.  Gowri holds a master’s Degree in Biosciences as well as the prestigious Regulatory Affairs Certification (RAC) awarded by the Regulatory Affairs Professional Society.  She is the author or co-author of several peer-reviewed research publications as well as book chapters. Gowri has breath of experience spanning R&D, CMC and Regulatory affairs. She also serves as a reviewer for several international Bioscience Journals for providing Scientific and technical expertise.

Session Details: Understanding Initial IND 30-09-2020, 12:00 pm View In Agenda

Biography: My work with gynecologists, nurse practitioners, physical therapists, other healthcare providers and their patients since 2002 in the treatment of female urinary stress and mixed incontinence made me keenly aware of how urinary incontinence reduces the quality of patients’ lives.  Despite the high efficacy of the pelvic floor exercise device we rented to them, patients with mild dementia could not remember the protocol, those with MS and paraplegia could not contract their pelvic floor muscles (PFM) and younger women busy with work and family responsibilities did not have the time to exercise.  Cheri Grantham, an experienced medical assistant, and I began developing a medical device which blocks unwanted urine leaks and does not require exercise or the cooperation of the patient.  I bring to this task over fifty one years of medical device experience, both in academia, private industry and consulting.  I have the leadership and technical skills, industry contacts and FDA experience to take this device all the way into the market so that we can greatly improve the quality of life of not just incontinent women, but of their caregivers and families, as well as saving third party payers such as Medicare a significant sum now paid to institutionalize some of these patients due to their incontinence, as well as funds paid for surgery and absorbent products. In previous positions I designed and ran local and international clinical trials of medical devices that diagnosed or treated eye diseases and skin conditions. Our team is currently navigating the difficulties COVID-19 has created for running a clinical study, both indirectly by keeping subjects home and directly by infecting one of our team members.

Session Details: Navigating the Unique Challenges Presented When Conducting Early Feasibility Studies 30-09-2020, 12:20 pm View In Agenda

Biography: Dr. Jane Royalty is an Internal Medicine Physician, ABIM Board-Certified, with 20 years of experience in clinical research and internal medicine. She has broad therapeutic area expertise in early phase protocol design and development including FIH through early patient trials, for small and large molecules, and all submission supporting studies. She also supports the oversight of special population clinical trials, including renal and hepatic impairment populations.

Session Details: Clinical Strategies for Optimizing Renal and Hepatic Impairment Studies 30-09-2020, 12:30 pm View In Agenda

Biography: Dr. Thomas Marbury has served as Principal Investigator in over 1,000 Clinical Trials since 1978. He has published extensively in scientific and clinical journals and is regarded as a thought leader in the area of renal and hepatic trials. He has presented on various panels with other clinical pharmacology experts and FDA leaders at the industry’s national meetings. He is the founder and President of Orlando Clinical Research Center since 1990. As the President of Orlando Clinical Research Center, his main areas of research are Phase I clinical trials.

Session Details: Clinical Strategies for Optimizing Renal and Hepatic Impairment Studies 30-09-2020, 12:30 pm View In Agenda

Biography: Michael is a Managing Partner of Medidata’s Patient Cloud solution sales team, providing leadership and subject matter expertise in decentralized clinical trials and patient centric technologies.  Over the last decade, Michael has worked collaboratively with sponsors, CROs, regulators, ethics committees and researchers around the world to pioneer the use of decentralization technologies for hybrid and virtual clinical trials. He was involved in providing solutions for the first decentralized clinical trial with FDA oversight in 2011 as well as PCORI’s ADAPTABLE study with more than 15,000 patients, and many other fully decentralized and hybrid clinical trials.  His 33-year career in medical research includes nearly a decade with the US government conducting and supporting surgical & preclinical research and more than two decades working in the commercial sector to provide technology solutions that improve and support preclinical and clinical research.  Michael is a decorated veteran of the United States Navy and resides in Brushy Creek, Texas where he is also an elected official serving his community.  

Session Details: Looking Beyond the Current Trend of Virtual Trials 30-09-2020, 12:50 pm View In Agenda

Biography: Jimmy is a Clinical Trial Specialist at Alnylam Pharmaceuticals. In his three and a half years in Clinical Operations, he has worked on studies from Phase 1 through 4, participated in multiple regulatory inspections, and helped to implement new projects and systems across clinical operations. He holds a Bachelor’s degree in Healthcare management and is currently pursuing a Master of Public Health degree at Boston University.

Session Details: Say it With Technology: How Alnylam Fosters a Connected Relationship with Sites 30-09-2020, 12:40 pm View In Agenda

Biography: Tennyson joined the Alnylam Clinical Operations department in November 2019 as a Clinical Trial Specialist for the Lumasiran program, where she has implemented creative lab sample solutions for a complex Phase III study. She joined Alnylam from Boston University Medical Center where she doubled as a Clinical Research Coordinator and Financial Manager in the Amyloidosis Center. Tennyson is a graduate of Boston University’s Questrom School of Business, where she received her MBA with a concentration in Health Sector Management in 2018 and Bachelors of Science in Business Administration in 2014.

Session Details: Say it With Technology: How Alnylam Fosters a Connected Relationship with Sites 30-09-2020, 12:40 pm View In Agenda

Biography: Lesley Freese has been a leader in implementing clinical technology to improve the conduct of trials for more than a dozen years. She was a site coordinator in the field of ophthalmology for six years, running multiple trials and managing the arrays of technologies from pharmaceutical sponsors. This inspired Lesley to move into a project management role at DrugDev, a company providing solutions that were truly making life easier for sites. In 2017, DrugDev was acquired by IQVIA. Lesley now serves as Associate Director of Trial Operations and continues to work with sites and sponsors to apply digital technologies to accelerate clinical trials.

Session Details: Say it With Technology: How Alnylam Fosters a Connected Relationship with Sites 30-09-2020, 12:40 pm View In Agenda

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Biography: Rangaprasad (Ranga) Sarangarajan, Ph.D., is the Chief Scientific Officer and SVP Clinical and Translational Sciences at BERG. He has oversight on all R&D activities and involved in the strategic planning and implementation of activities related to pharmaceutical and clinical developmental activities. Dr. Sarangarajan is the co-inventor and co-architect of the BERG Interrogative Biology® technology; currently focused on next generation R&D innovation in the integration of artificial intelligence based analytics, bioinformatics and RWD/RWE utility for speeding up identification/validation of targets, tractability, drug discovery & pharmaceutical development. Dr. Sarangarajan has numerous US and international patents (granted and pending), covering areas of the discovery platform, cancer, neurology, metabolic diseases, diabetes, obesity and diagnostics. He has published extensively and has presented his research in national and international medical and scientific meetings. He co-authored and co-edited Cellular Respiration and Carcinogenesis, a first of its kind treatise on the role of mitochondrial function and metabolic network regulation in the etiology of cancer as it pertains to the seminal observations made by Otto Warburg. Dr. Sarangarajan has a B.S. in Pharmacy and graduate degree in Pharmaceutical Sciences from the University of Cincinnati College of Pharmacy with focus on pharmacology and toxicology. He went on to pursue post-graduate training in genetics, molecular and cell biology for several years prior to joining Massachusetts College of Pharmacy and Health Sciences (now MCPHS University) and served in capacity of Assistant/Associate Professor.

Session Details: Molecular Mapping, AI and Analytics: Filling the Chasm(s) for Clinical Success 30-09-2020, 1:40 pm View In Agenda

Biography: Tim McCarthy is VP & Head of Digital Medicine & Translational Imaging in Early Clinical Development at Pfizer. His team has two areas of focus: Digital Medicine, a group dedicated to the evaluation, qualification and operationalization of sensors and wearable technologies as novel endpoints in clinical trials and; Clinical & Translational Imaging, which works across the enterprise to provide imaging expertise (e.g. MRI, PET, CT, Ultrasound) and solutions to teams in both early (idea to proof of concept) and late-stage development. Tim has a background in Positron Emission Tomography, which he obtained during his time as a faculty member in Radiology at Washington University School of Medicine in St Louis. In 2001 Tim joined Pfizer to pursue his interests in applying translational imaging to drug development. Following the Pfizer acquisition, he has had roles of increasing responsibility and was most recently appointed to his current role in 2018. He is based in Cambridge, MA. Outside of Pfizer, Tim has been active in the imaging community; he was President of the Academy of Molecular Imaging (AMI) from 2008-11 and he is a founding director and past-president of the Society of Non-Invasive Imaging in Drug Development (SNIDD). Tim received his B.Sc. and Ph.D. in Organic Chemistry from the University of Liverpool, UK and his MBA from Washington University in St Louis.

Session Details: Site engagement during the site feasibility process and the impact on study start-Up timelines 30-09-2020, 1:50 pm View In Agenda

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Session Details: Site engagement during the site feasibility process and the impact on study start-Up timelines 30-09-2020, 1:50 pm View In Agenda

Biography: Behtash Bahador is an Associate Director at the non-profit organization CISCRP, and holds a Master of Science in Health Communication from the Tufts University School of Medicine. Since 2014, he has collaborated with a range of stakeholder groups to establish and implement patient- and public-centric initiatives across the life-cycle of drug and treatment development. This has included supporting the development of regulatory and cross-disciplinary best practice guidelines, operationalizing key elements of evidence-based public health programing into research engagement activities, and always keeping the needs of patients, participants and the public at the forefront of his work.

Session Details: This is Not a Trend: Exploring Why Patient-Centered Clinical Research Will Continue to Change the Research Paradigms of the Past and the Impact it Can Have 30-09-2020, 1:30 pm View In Agenda

Biography: Drew’s career in pharmaceutical technology spans over 20 years and includes significant experience in eClinical system architecture, design, and development, as well as process design, solution validation, and international implementation and support. Drew spent the majority of his career prior to Veeva at PAREXEL, where he led the operational institutionalization of EDC, quickly increasing the utilization of EDC from 25% to over 95% in less than two years. Next, Drew and his team developed technology solutions in large scale partnerships and focused on driving the development and standardization of risk-based monitoring tools and techniques. Drew’s innovative solutions in risk-based monitoring earned him a prestigious industry “Clinical Innovator of the Year” award in 2015. Drew joined Veeva in 2016 as Vice President of Product Management and led the ground-up design of Veeva’s Vault EDC solution. In his current role of Chief Technology Officer at Vault CDMS, Drew shares and collaborates with customers, partners, and the industry to set vision and direction of Veeva’s CDMS product.

Session Details: Time to Reconsider EDCs 30-09-2020, 2:10 pm View In Agenda

Biography: As PRA's Chief Scientific Officer, Mr Thoelke provides corporate oversight and strategy for Scientific & Medical Affairs, Pharmacovigilance & Patient Safety, Therapeutic Centers of Excellence, Real World Data, Patient Access & Experience, Digital Health & Virtual Trials, and their integration into operational delivery. Mr Thoelke is an industry pioneer in the application of mobile first strategies, which integrate clinical trials and provide access directly to patients in both virtual and hybrid-virtual models. He emphasizes leveraging real world data, social insights, and patient connectivity to advance global drug development.

Session Details: Exploring the Use of Decentralized Trials Models as the new normal 30-09-2020, 2:20 pm View In Agenda

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Frank Leu is a Co-Founder and CEO of Novapeutics at Philadelphia, PA - a biopharma spun-out from the University of Pennsylvania, developing a first-in-class small molecule beta-cell restoration curative for type 2 diabetes. Prior, Frank was at a specialty pharma Verto Institute, developing biologic therapeutics for treating the neuroendocrine cancer. Frank graduated with a Pharmacology Ph.D. from Weill Cornell Graduate School of Medical Sciences in 2001, and then post-doc in a Howard Hughes Medical Institute laboratory at the Rockefeller University in molecular enzymology. He has served as an adjunct instructor at the Rutgers Cancer Institute of NJ, and is an adjunct professor at the pharmacology department of the Thomas Jefferson Medical University. Frank also founded BioPharMatrix developing blockchain solutions to lifescience innovations at all phases, and serves as advisor to the Pennovations center working with 1776 / Benjamins Desk. Frank is a thought leader in the blockchain architecture innovations in the life-sciences and drug development, Frank serves on multiple advisory boards and frequently served as chairman, speaker, moderator, and facilitator for many life-sciences and drug development events.

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Biography: James L. Sherley, M.D., Ph.D. is the founder, President, and CEO of Massachusetts stem cell biotechnology company Asymmetrex, LLC. Asymmetrex develops and markets technologies for advancing stem cell medicine, including the first method achieving specific and accurate certification of the dosage of therapeutic tissue stem cells, called kinetic stem cell (KSC) counting. Asymmetrex’s kinetic stem cell counting platforms are also used to optimize manufacturing of therapeutic stem cells and for evaluations of drug effects on tissue stem cells. Dr. Sherley is a graduate of Harvard College, with a B.A. degree in biology, and the Johns Hopkins University School of Medicine, earning joint M.D. and Ph.D. degrees. Prior to founding Asymmetrex, he held academic research appointments at the Fox Chase Cancer Center, Massachusetts Institute of Technology, and Boston Biomedical Research Institute. Dr. Sherley’s professional awards include Pew Biomedical Research Scholar, Ellison Medical Foundation Senior Scholar in Aging Research, and NIH Director’s Pioneer Award.

Session Details: How Can We Outsource Stem Cell Clinical Trials Without Counting Tissue Stem Cells 30-09-2020, 2:50 pm View In Agenda

Biography: Jennifer Lee is Senior Vice President of Clinical Operation, Biostats, and Data Management at Elevar Therapeutics. Jennifer brings over 25 years of industry expertise in clinical strategies, asset evaluation, and advancing novel and innovative clinical programs spanning phases I-IV across therapeutic areas, including oncology, infectious disease, inflammation, urology, CNS, cardiovascular, rare disease, and stem and cell therapies. She is an invited speaker at international conferences and has successfully submitted market applications leading to seven NDA approvals. Previously, Jennifer worked at G.D. Searle, Pharmacia, Pfizer, Astellas Gilead Sciences, and other mid- and micro-cap companies. Jennifer holds a BS in Biochemistry from the University of Illinois and an MS in Clinical Research and Regulatory Administrations from Northwestern University. She is an active mentor, Women in Bio supporter, and board member.

Session Details: Assessing the Benefits and Challenges of Integrating Technology in Oncology Trials; what does the future hold for your trials? 30-09-2020, 2:40 pm View In Agenda

Biography: As Founder and Chief Executive Officer of Axiom Real-Time Metrics, Andrew Schachter delivers the visionary leadership integral to the company's 20 years of eClinical technology and Managed services success. Under his leadership, Axiom has grown into a well-established and recognized innovator and leader in the small-to-medium life science Clinical solutions landscape. His expertise and profound understanding of complex clinical studies have transformed the Axiom global team into a devoted and virtuous leader in the industry. Over the past 20 years, Schachter's passion for innovating technology solutions continues to drive Axiom to empower smarter and faster clinical studies and yield better study results for helping patients worldwide. Today, Axiom's state-of-the-art unified eClinical Suite Fusion has over 15 powerful and highly configurable modules. In addition, Axiom also offers global clients intelligent Data Management, Data Analytics, Pharmacovigilance & BioStats services.

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Biography: As the CEO of Agilex Biolabs, and previously the founding CEO of CPR Pharma Services, Jason’s passion for scientific excellence ensured that Agilex Biolab’s exacting scientific standards are maintained. Jason is the driving force behind Agilex Biolab’s ethos of excellence in customer service and Quality Assurance, and he maintains close relationships with existing and potential customers. With over 15 years’ experience in the pharmaceutical industry, Jason brings a wealth of knowledge and expertise to the company. Winner of the 2008 BioInnovation SA Young Achiever of the Year Award, Jason is highly skilled in the management of service provision facilities. He has a Bachelor of Science in Chemistry.

Session Details: How easy is it to move your clinical trials to Australia? 30-09-2020, 3:20 pm View In Agenda

Biography: Harry Barnett Harry is the co-founder and Executive Chairman of Lubris BioPharma, a clinical-stage biotech company developing a proprietary version of the novel, ubiquitous human protein, PRG4, for use in multiple indications.  Novartis owns rights to Lubris’ technology for ophthalmology. Harry’s two-decade life science career includes: (i) co-founding and executive management roles at three life science companies and two CROs; (ii) incubating, partnering and licensing successfully a wide array of pharmaceutical products and technologies including Pepcid Complete®, the OTC hearburn remedy sold by J&J, and; (iii) innovating multi-center, clinical trial processes using techniques that have been adopted as industry standard.  Prior to his transition to life science and biotech, Harry was a transactional business lawyer in private practice at DLA Piper in San Diego, and later at Faneuil Advisors, Inc., an investment advisory firm based in Boston where he served as General Counsel and Executive Vice President.

Session Details: Finding and Selecting the Right CRO in an Increasingly Competitive Market 30-09-2020, 3:30 pm PANEL DISCUSSION How has Covid-19 affected your trial and what impact has it had on your partnerships 01-10-2020, 12:00 pm View In Agenda

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Session Details: PANEL DISCUSSION: Novel Digital Endpoints in Clinical Research: Technology, Infrastructure, Relationship with Technology Providers 30-09-2020, 3:40 pm View In Agenda

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Session Details: PANEL DISCUSSION: Novel Digital Endpoints in Clinical Research: Technology, Infrastructure, Relationship with Technology Providers 30-09-2020, 3:40 pm View In Agenda

Biography: Heather Haselmann has been with Canfield since 2005.  She started as Project Manager and grew to role of Associate Director of Clinical Services overseeing project teams.  This led her to current role as Director of Business Development in which she is able to speak to the team’s expertise and create solutions for their clients.  Heather is responsible for communicating the breadth and depth of clinical project management services, ensures customer service provided at the highest levels, including proposals and follow through of deliverables.  Heather has extensive knowledge of the industry which covers Dermatology, from hair growth to onychomycosis and skin conditions, Aesthetics, Body Contouring, Oncology and Rare Diseases related to skin.

Session Details: Building Confidence with Photographic Documentation: from early phase clinical trial to marketing projects 30-09-2020, 4:00 pm View In Agenda

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Session Details: Getting Clinical Trials Back on Track 30-09-2020, 4:10 pm View In Agenda

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Session Details: Getting Clinical Trials Back on Track 30-09-2020, 4:10 pm View In Agenda

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Session Details: Exploring the Use of Technology as a Tool for Successful Patient-Centric Trials Resulting in Enhanced Patient Retention 01-10-2020, 9:10 am View In Agenda

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Session Details: Keynote: Effectively using technology such as Artificial Intelligence (AI), Deep Learning (DL) and Machine Learning (ML) within medical device trials to enhance medical device trials 01-10-2020, 9:20 am View In Agenda

Biography: Dan DeBonis is one of the pioneers and leaders at the forefront of innovation for eCOA, outcome analytics and the integration of digital technologies in clinical research.   He is an entrepreneur, a co-founder of several companies, including Concordant Rater Systems, which  became part of what is now Signant Health in 2010.   Throughout his career, he has integrated key stakeholders, including clinicians, developers, KOLs, patients and regulators, into technology driven solutions to improve the quality and integrity of clinical trial data.   More recently, Dan has been a leader on COVID-19 response and mitigation strategies for Signant Health and our clients.   He has served as an advisor to a range of companies from start-ups to large pharmaceutical companies.   Dan is the author of a patent and publications on technologies in clinical research.  He is a graduate of Yale University, and resides with his young family in Boston.

Session Details: The ‘New’ Status Quo: Technologies, Best Practices and the Role of Sites for Clinician Administered Outcomes (ClinROs) 01-10-2020, 9:30 am View In Agenda

Biography: With a career spanning more than two decades, Mrs. Jackson brings a wealth and breadth of knowledge and experience which is highly valued; providing key Regulatory Operations and TMF Management consulting guidance to Regulatory and Clinical Operations departments.  Working with large and small pharmaceutical and biotechnology companies has allowed Tamika to develop proven methodologies in any organization required to prepare, submit, manage, track and produce “real-time” inspection ready TMFs and regulatory submissions to ensure agency approval.  Tamika, along with her SWAT team of professionals, now work to efficiently and effectively evaluate companies’ resources, processes, documentation, systems, and TMF Management activities to methodically streamline the operation from end-to-end.

Session Details: Common Risk Factors To Address In Order To Maintain “Real Time” Inspection-Ready TMFs 01-10-2020, 9:50 am View In Agenda

Biography: Justin Albani is the Director of Imaging Services at Invicro, an imaging solutions provider specializing in the application of imaging biomarkers in drug development and clinical research. Justin has over ten years of experience in clinical research and medical imaging, where he focused on imaging operations and data collection, review, and standardization. At Invicro, Justin is responsible for the oversight of global training and imaging equipment qualification across center’s participating in Phase I -III clinical trials, as well as imaging data receipt and processing.

Session Details: Obtaining High Quality Imaging Data from Clinical Trials 01-10-2020, 9:40 am View In Agenda

Biography: Hyun has been a part of AOBiome’s clinical pipeline leadership since 2016. Hyun brings over 24 years of drug development experience in the pharma and biotech industry. Prior to this, Hyun has led Clinical and R&D programs and departments at Pfizer, Anika Therapeutics, Transport Pharmaceuticals, and Olympus Biotech. He started his career at Genetics Institute and Wyeth, where he developed biologics for tissue repair. He attended Brown University where he studied Biomedical Engineering and completed a PhD in Medical Science.

Session Details: Determining How to Find the Right Partner to Conduct your Early Clinical Study 01-10-2020, 10:10 am View In Agenda

Biography: John has 15+ years of experience in the medical device and pharmaceutical industry with responsibility for people management/development, global clinical trial management, regulatory strategy, and leading product development processes with emphasis on comprehensive regulatory and clinical strategy and product risk management. John’s experience in clinical and regulatory includes leading multiple Investigational Device Exemption IDE Trials, regulatory submissions, and FDA communications in a variety of indications including spine, neurosurgical, cranial, pulmonology, gastroenterology, diagnostics (IVDs), women’s health, and vascular surgery devices.

Session Details: Understanding Strategy and Logistics for Global Medical Device Trials and Ensuring the Best Practices when Expanding to New Territories 01-10-2020, 10:20 am View In Agenda

Biography: Rob leads Schlesinger Group’s Clinical Research and Healthcare Divisions. Rob joined Schlesinger in 2013 and has over twenty-five years’ experience developing and managing healthcare industry marketing research and, more recently, clinical research strategies. Rob provides a unique view of the healthcare research landscape, having worked for Ipsos Healthcare, where he served as SVP. Before that, Rob was Vice President, Healthcare Research at Ipsos Understanding, where he ran the qualitative health division for Ipsos. Rob has also held senior positions at Oxford Health Plans (MCO), Merck Medco (PBM), Observant, and Pfizer. Rob has an MBA in Health Care Administration and a Bachelor of Arts degree in Marketing and Advertising.

Session Details: A Clinical Data Partner For The 'New Normal' 01-10-2020, 10:30 am View In Agenda

Biography: Erica Figueroa began her clinical research career with Thermo Fisher Scientific, specializing in cGMP raw materials, clinical supplies, and global logistics. In 2017, Erica transitioned to work for Clinical Research Organizations (CROs) to be closer to patients, focusing on managing global clinical trials in pre-clinical to phase 4. Erica has worked on some of the most complex client engagements and thrives on building strategic partnerships with start-ups and those with an advanced pipeline of assets. She is highly involved in clinical research industry events, such as Outsourcing Clinical Trials, ACRP, JP Morgan, PDA, DIA, Women in Bio, and ASCO.

Session Details: A Clinical Data Partner For The 'New Normal' 01-10-2020, 10:30 am View In Agenda

Biography: Staci has 20 years of experience in the field of clinical research in both biomedical and social and behavioral sciences. She has served in various academic and industry roles, managing and implementing clinical trials throughout their entire life cycle and has extensive experience with both investigator-initiated and sponsor-initiated clinical trials, working with many of the leading industry sponsors and CROs. Staci has significant experience in device trials, focusing on Patient-Reported Outcomes (PROs) and Clinical Outcomes Assessments (COAs), including electronic implementation and migration. She contributes to scientific publications in peer-reviewed journals focused on clinical outcomes. Most recently, she served as the Institutional Review Board (IRB) Administrator for the Mercy Health System, spanning four states.

Session Details: A Clinical Data Partner For The 'New Normal' 01-10-2020, 10:30 am View In Agenda

Biography: Heather helps clients answer their critical business questions and complete clinical studies by comprehensively managing their research needs. Heather is an exceptional problem-solver who, in a high-performance culture, fosters innovative and skillful solutions to ensure clients can meet their clinical research goals and objectives on time, to spec and within budget. She approaches business from a sense of partnership and is deeply committed to fostering longstanding relationships with clients. Heather serves as Vice President of Intellus Worldwide and co-chairs the award-winning and published Health Literacy Initiative. She has deep experience in pharmaceutical research, and was a 2016 recipient of the PMRG Circle of Excellence Award. Heather has a Bachelor’s degree in Public Relations and Applied Communication in Organizational Settings

Session Details: A Clinical Data Partner For The 'New Normal' 01-10-2020, 10:30 am View In Agenda

Biography: Joanne is a CRA Manager working for more than 11 years at SGS Life Science Services. She has over 18 years of Clinical Research Industry experience. In her current role as CRA Manager Joanne directly managed as many as 40 CRAs across 8 projects in various phases.

Session Details: Risk Based Monitoring Through COVID-19 and Beyond: Advancing Structured Flexibility 01-10-2020, 10:40 am View In Agenda

Biography: Claire Sears is the Director, Site Identification & Feasibility, IQVIA Technologies. Claire firmly believes closer relationships between investigators, sites and industry can bring great benefits to the clinical trial process. Prior to IQVIA Technologies, Claire worked for AstraZeneca in their clinical and commercial departments in scientific communications and medical affairs roles on products in all phases of development across several therapy areas. Claire has a background in scientific research, with a Doctorate in cardiovascular research.

Session Details: Creating a Balance - Managing Risk & Optimizing Timelines in Feasibility 01-10-2020, 10:50 am View In Agenda

Biography: Dr. Rosenberg is a 30 plus year executive with proven experience in driving operational excellence at all levels within the pharmaceutical, biotechnology, eclinical and contract research organization sectors. With his diverse background which includes executive management, clinical and regulatory operations, business development, eclinical technology solutions and new product/licensing evaluations, he brings tremendous hands on insights to optimizing the drug development cycle, from the early start-up stage to global product registration across many key therapeutic areas including CNS and oncology. Dr. Rosenberg is Managing Partner of eP2Consulting, Inc. since 2001. He also currently serves as Head, Clinical Operations at Beat AML, LLC, a division of The Leukemia & Lymphoma Society. Dr. Rosenberg received his Ph.D., from the Kellogg Pharmaceutical Clinical Scientist Program, University of Minnesota, College of Pharmacy and his Bachelor of Science, Pharmacy, from the Philadelphia College of Pharmacy and Science. Contact Information: 4 Quail Court, Mount Laurel, NJ 08054 (c: 609-923-9443)

Session Details: Lessons Learned from Master/Basket Trials Clinical Operations 01-10-2020, 11:00 am View In Agenda

Biography: Adrian Orr is the Executive Director of Clinical Affairs at Anika Therapeutics, Inc in Bedford, MA. Adrian has previously worked in a range of small to medium-sized medical device and biologics companies including Gyrus Medical, Serica Technologies, and Haemonetics. He has focused on re-structuring and developing clinical teams to tackle technically challenging surgical and biologics trials. Adrian’s current focus is on joint preservation and tissue regeneration in orthopedics. His talk today will center on the use of eDiaries in clinical research.

Session Details: Understanding strategy and logistics for global medical device trials and ensuring the best practices when expanding to new territories 01-10-2020, 11:10 am View In Agenda

Biography: Lori Kahler is the Founder and Managing Director of The RC Insight Group.  Ms. Kahler has over 25 years’ experience in the medical device industry that spans across operations, quality, compliance, regulatory and clinical affairs.  Positions previously held include Global Vice President of Operations and QARA for INVO Bioscience, where Ms. Kahler was instrumental in achieving FDA De Novo clearance for INVO Bioscience’s innovative INVOcell® System; Director of Regulatory and Compliance for Samsung Electronics America (Health and Medical Equipment); Vice President of Regulatory and Clinical Operations for Ximedica; and Global Director of Quality Operations and Regulatory Affairs/ Managing Director Asia Pacific Region for Agfa Healthcare.

Session Details: Developing Strong Partnerships to Ensure Clinical Trial Success 01-10-2020, 11:20 am View In Agenda

Biography: Catherine (Cat) Hall started her career as an academic scientist in Molecular and Cellular Biology before finishing her MBA and transitioning into Pharmaceutical Supply Chain Management. During her career, she developed notable expertise not only in clinical supplies but also in training development, process improvement, managing partnerships, and the design and implementation of technologies such as Interactive Response Technology (IRT).  She is well-known for focusing on bridging the GMP/GCP gap by bringing supply chain customer service through the last mile to patients. Cat joined endpoint in 2019 as VP of Product Strategy to help continue to bring the customer voice forward into shaping the future of IRT. She was recently promoted to VP of Clinical Innovation and Quality where she will have oversight of the Testing Organization as well as Product Strategy and QTC ensuring that endpoint’s Quality by Design strategy is implemented successfully and proven with every project.

Session Details: A Deep Dive into Virtual Trials and Direct-to-Patient Logistics 01-10-2020, 11:40 am View In Agenda

Biography:

Megan brings nearly 23 years of industry experience across a broad range of therapeutic areas, including oncology, infectious disease, pain and respiratory with a focus on project management and clinical operations at both pharma and CROs.  She has experience with several types of agents with a specific interest in advancing cellular immunotherapeutics.  Megan recently presented at the ISCT Commercialization Series on start-up considerations for global expansion of cell therapy trials and previously presented a webinar entitled ‘Operational Excellence in Immuno-Oncology Clinical Trials’.  As a member of Precision’s Adoptive Cell Therapy working group, she works with scientific, medical and clinical operations experts to stay abreast of recent developments in this evolving space as well as assist in the standardization of forms, templates and trainings to promote consistency in execution of these trials at Precision.

Session Details: Driving Innovations in Clinical Trials 01-10-2020, 11:50 am View In Agenda

Biography: Anthony Costello is Senior Vice President of Patient Cloud at Medidata.  After beginning his clinical research career at Genentech 20 years ago,  Anthony Costello has gone on to co-found several clinical trials technology start-up companies including Nextrials (acquired by PRA Health Sciences) and Mytrus (acquired by Medidata).  Over his career, he has focused on disruptive and innovative technology that can simplify clinical trials for patients, sites and sponsors.  He has been selected as one of the PharmaVoice Top 100 Most Inspiring People in Clinical Research, has served as Chairman of the Board for the Society for Clinical Data Management and is currently a member of the editorial advisory board for Applied Clinical Trials magazine.  He is a frequent author and presenter on topics related to the efficient use of technology in clinical research.

Session Details: PANEL DISCUSSION How has Covid-19 affected your trial and what impact has it had on your partnerships 01-10-2020, 12:00 pm View In Agenda

Biography: Gabrielle DeBartolomeo is the clinical trial scientist at Alkeus Pharmaceuticals, a Boston-based biotech focused on developing treatments for rare and common forms of currently untreatable blindness including age-related macular degeneration and Stargardt disease. Wearing multiple hats in the company, she is responsible for clinical operations activities and coordinates operational and regulatory activities with private practice and academic sites, in addition to leading patient outreach and support. Through this role, she has witnessed firsthand the multidimensional impact of COVID-19 on clinical trials.

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Session Details: Catalyst Clinical Research Panel Discussion: Decentralized Trials: A Real-World Example 01-10-2020, 12:55 pm View In Agenda

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Session Details: Catalyst Clinical Research Panel Discussion: Decentralized Trials: A Real-World Example 01-10-2020, 12:55 pm View In Agenda

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Session Details: Catalyst Clinical Research Panel Discussion: Decentralized Trials: A Real-World Example 01-10-2020, 12:55 pm View In Agenda

Biography: Ken is the Director of Sponsored Research and Associate Professor at the Tufts Center for the Study of Drug Development, and Chairman of the Center for Information and Study on Clinical Research Participation, a non-profit organization that he founded to raise public and patient awareness of the clinical research enterprise. He is founder and owner of CenterWatch, and an owner and board member of the Metrics Champion Consortium. A well-known speaker at symposia, universities, and corporations, Ken has published extensively in peer-reviewed journals, books and in the trade press.  He has been an active DIA member for 25 years and has held board appointments in the private and public sectors.  Ken earned his MBA from Northwestern University.

Session Details: Macro Trends Impacting Drug Development Performance: Insights Moving Forward 01-10-2020, 2:00 pm View In Agenda

Biography:

Bill Cooney founded MedPoint Digital in 1990. As President and CEO, he continues to lead the strategic growth of a world-class digital services company to the medical industry. Prior to launching MedPoint, Bill was on the Executive Committee and helped start-up Discovery International, the medical education arm of Publicis Healthcare.

In the 1980s, Bill worked in sales and marketing positions at Wyeth and Abbott. He was Business Unit Manager for the Depakote brand at Abbott, and helped form the first telemarketing sales department at Abbott.

Throughout his career, Bill has spoken at numerous healthcare industry events and bylined articles in pharmaceutical trade journals on topics ranging from medical education to research training and digital technology. Bill is Chairman of the Board of Directors for Healthcare Consultants International, Inc., a company providing training and consulting services to healthcare providers and facilities. Bill holds an M.B.A. from the Fisher College of Business of The Ohio State University and a B.A. from The University of Virginia.

Session Details: COVID-19 and Digital Acceleration 01-10-2020, 2:30 pm View In Agenda